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Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

NCT04143906 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-10-30

No results posted yet for this study

Summary

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A: Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;

Conditions

Interventions

DRUG

Vinorelbine

injection

DRUG

Gemcitabine

injection

DRUG

Carboplatin

injection

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Zhiyong Yu, PhD · Shandong Cancer Hospital and Institute

  • Liang Zhang, MD · Shandong Cancer Hospital and Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2024-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143906 on ClinicalTrials.gov